The FDA is Also Slow at Hiring

by on November 3, 2016 at 11:30 am in Economics, Medicine | Permalink

One of the reason’s the FDA is too slow to approve new drugs is that as a branch of the Federal government they are tied to slow and inefficient hiring rules.

The Food and Drug Administration has more than 700 job vacancies in its division that approves new drugs, and top officials say the agency is struggling to hire and retain staff because pharmaceutical companies lure them away.

“They can pay them roughly twice as much as we can,” Janet Woodcock, who directs the FDA’s Center for Drug Evaluation and Research (CDER), said at a rare-diseases summit recently in Arlington, Va.

High-value, potentially life-saving drugs are being delayed because the FDA is constrained from paying market rates. Absurd. Moreover, it’s not just about the wage rate.

[Janet] Woodcock [Director of FDA’s Center for Drug Evaluation and Research] wrote in December that staffing was a priority in 2016 because the center had “more than 600 staff vacancies.” At the Arlington event, she called the federal hiring system “challenging,” adding that prospective candidates often take other jobs while waiting for the FDA to make an offer.

“We move rather slowly — like a snail might be a better analogy,” agreed Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “A young person with a family can’t wait four months for us to get through some of the federal hiring process. So if they have something else that’s more . . . expedient, they will take that.”

Sadly, slow and bureaucratic describes not just the hiring process but the drug approval process. The only difference is that patients don’t have an option to take the expedient alternative.

1 Rock Lobster November 3, 2016 at 11:32 am

They probably can’t pass the drug test.

2 Ray Lopez November 3, 2016 at 11:32 am

I think FDA hires are mostly lower income people of color so I would imagine there’s plenty in the DC area to satisfy the FDA. False alarm if you ask me. What do they do anyway? Foot drag, etc, which anybody can do. Not like you need to be a rocket scientist.

3 JFA November 3, 2016 at 1:01 pm

This might be one of the most idiotic comments I’ve read on this site.

4 AlanG November 3, 2016 at 1:18 pm

Agree with JFA. I know lots of people at the FDA and I’ve worked with them in the past when I as still in drug regulatory affairs. The folks are MD, PhD, and other advanced degrees. they work tirelessly beyond the 40 hour work week to review new therapeutics. It’s easy for Alex and others to throw stones when they don’t have any idea what goes on at the agency.

5 Ray Lopez November 3, 2016 at 1:37 pm

Well in my professional capacity well over a decade ago I dealt with the FDA and they seemed like a bunch of recently graduated no-nothing Latins and blacks. Not that I have anything against these people, or you people as R. Pirot might say. Know-nothings… reminds me of an (the) American Party (https://en.wikipedia.org/wiki/Know_Nothing)

6 mulp November 3, 2016 at 2:53 pm

Well, we know from conservatives, who are always correct, that government workers are way over paid. So, as soon as they learn their job, they leave for lower paid private sector work.

7 Jan November 3, 2016 at 9:21 pm

Despite being an idiot, that’s just wrong. I meet with FDA all the time. Large majority of the staff are white and Asian, usually smart folks with advanced degrees. I think you were meeting with the security guards.

8 Careless November 4, 2016 at 11:46 pm

It’s rather obvious based on how AA works that when you control for advanced degrees, the least intelligent whites and Asians who get them will wind up being hired for the lowest paying jobs in the tier.

9 Careless November 4, 2016 at 11:44 pm

Ray Lopez has spent what, 5 years proving himself to be a moron here? This post is not surprising.

10 academia macht frei November 4, 2016 at 3:45 am

as a recently retired fedgovt worker, i concur–the fda most likely is waiting for dark-skinned applicants with an appropriate phd…disgusting…and what is worse is that after they are hired the mgmt will not make them work as hard as lighter skinned workers…trust me, i know…

11 Jan November 4, 2016 at 5:54 am

I don’t think you’ve been to FDA’s campus. There are few “dark-skinned” people and they are mostly in the lower tier jobs, security guards and admin assistants. But trust me, if they could find people with the right credentials willing to work for the salaries they offer, they’d hire them no matter what color they are. Industry and Congress both are pissed at FDA for not hiring fast enough.

12 Li Zhi November 3, 2016 at 11:50 am

Context? Oh, why would anyone need to know 1) the total number of employees at the FDA or 2) the average turn-over rate or 3) educational requirements for the various levels? Perhaps the FDA should start a Apprentice/Journeyman/Master program. Seems to me the employees need foremost to understand basic statistics and human physiology and some biochemistry and then be able to find the expertise to answer their questions. I find it pretty laughable that they’re suggesting “pharmaceutical companies” are hiring lots of bureaucrats. How many years of “education” does it take to learn to say “no”?

13 The Free Market Is Not God November 3, 2016 at 12:08 pm

What is this context thing? The free market doesn’t allow context. It’s much more simple than that. Nothing gets done in the free market, unless some large company, or some large political donor, can make a killing off of it. I guess no large political donor drug company can make a killing from the FDA becoming efficient. So it doesn’t.

14 Ray Lopez November 3, 2016 at 12:19 pm

I think AlexT’s concern is with consumer welfare rather than producer surplus. As you say, the more red tape the better it is for established companies that have mastered the red tape. The red tape is a barrier to entry for new competitors to Big Pharma.

15 AlanG November 3, 2016 at 1:19 pm

Do you have any idea how the drug approval process works? Can you provide a concrete example of ‘red tape?’

16 jonathan November 4, 2016 at 4:02 am

Are you kidding? The longer it takes and the more expensive it is to bring a new drug to market (currently *years* for many drug categories), the better it is to be a large incumbent company and the correspondingly harder it is to survive as an upstart. This is by design.

Any simplifications to the approval process represent the potential for new competitive threats. Adding more steps, complications and roadblocks (including due to under-staffing) are understood as *features*, not bugs, of such a system, by these companies who have successfully played the game called regulatory capture. And as usual, consumers and taxpayers foot the bill.

Where is the red tape, indeed.

17 mavery November 3, 2016 at 1:24 pm

FDA regulators with only a “basic” understanding of statistics is a great way to get drugs that don’t work approved. It’s also a great way to get well-designed clinical trials hung up because the regulators aren’t familiar with the techniques being used.

You think the FDA is a bunch of bureacrats? The people they need are statistics PhDs. I interviewed with them when I got done with grad school (biostatistics wasn’t even my area of interest) and at the time they were pretty desperate. I imagine its only gotten worse since.

When companies are paying any PhD physicist with coding experience $150,000 to come be a “data scientist”, its unsurprising that the FDA is struggling to hire real statisticians given their low rates.

18 mulp November 3, 2016 at 2:59 pm

Governight workers are way over paid!

Reducing the Costs of Federal Worker Pay and Benefits
Chris Edwards
September 20, 2016
The federal government employs 2.1 million civilian workers in hundreds of agencies at offices across the nation.1 The federal workforce imposes a substantial burden on America’s taxpayers. In 2016 wages and benefits for executive branch civilian workers cost $267 billion.2

Since the 1990s, federal workers have enjoyed faster compensation growth than private-sector workers. In 2015 federal workers earned 76 percent more, on average, than private-sector workers.3 Federal workers earned 42 percent more, on average, than state and local government workers.4 The federal government has become an elite island of secure and high-paid employment, separated from the ocean of average Americans competing in the economy.

https://www.downsizinggovernment.org/federal-worker-pay

Overpaid Federal Employees
By NICOLE KAEDING SHARE
With the election only weeks away, pundits are visualizing how a Republican-controlled Senate would impact future policy decisions. Today’s Washington Post highlights the supposed plight of federal workers under a Republican Congress.

The piece discusses House Budget Chairman Paul Ryan’s budget proposal:

Under the Ryan budget, the contribution of most federal employees toward their retirement plan would increase by 5.5 percentage points with no increase in benefits — effectively a pay cut. Ryan emphasizes a “defined-contribution system” that centers on employee payments to their retirement program instead of the current system, which includes pensions from the U.S. government. He estimated his plan would save the government $125 billion over 10 years.

That $125 billion in savings, however, would come from the pockets of federal employees.
The piece continues in a similar vein discussing Republican-supported legislation that would make it easier for federal employees to be disciplined, fired, and restricted in their conference expenditures–all reasonable proposals. It cites federal employee union officials on the difficulties these policies would place on federal workers.

But the piece fails to mention the elephant in the room: federal employees are compensated more generously than their private-sector counterparts.

Using data from the Bureau of Economic Analysis, the average wage for a federal civilian employee in 2013 was $81,076, compared to the average wage of $55,424 for private-sector employees.

The big advantage for federal employees is their robust benefit packages. Federal employees receive the largest selection of health insurance of any employer in the country, generous vacation and time-off policies, and both a defined benefit pension and 401(k)-style retirement account. Adding in the value of these benefits, the average federal civilian employee receives annual compensation of $115,524. Compensation for the average private-sector employee is $66,357.

Particularly striking is that availability of pensions to federal employees. According to the Bureau of Labor Statistics, only 10 percent of private-sector employers are offered defined benefit pension plans. The majority of recipients are unionized employees, concentrated in the utilities industry.

https://www.cato.org/blog/overpaid-federal-employees

19 kevin November 3, 2016 at 3:30 pm

You should get a job as a government worker if you think they’re overpaid. I’m sure some are, but the fact that thousands of individuals turn down government work to work in the public sector (which is what this article is about) clearly demonstrates they all aren’t.

20 Alain November 3, 2016 at 9:12 pm

Software (which is what mavery noted) is in great demand in the private sector. This means that the government simply has a hard time competing in this field and that employees in government who “write software” are likely underpaid.

However government has many “functions” and not all are software, in those fields the government overpays.

21 JFA November 3, 2016 at 4:06 pm

From the Chris Edwards report: Studies from the CBO, AEI, and Heritage Foundation “found large differences based on education levels. Among less-educated workers, the federal government pays better, but among highly educated workers, the private sector pays better.”

22 Troll me November 3, 2016 at 1:57 pm

“How many years of “education” does it take to learn to say “no”?”

Touché

23 mb November 3, 2016 at 11:52 am

probably not pharma, but consulting companies that help pharma comply with regulation. Every former FDA person I meet is a consultant.

which always cracks me up, making opaque hard to follow rules guarantees them a very good job when they retire…

24 AlanG November 3, 2016 at 1:20 pm

The companies that need these consultants are the unsophisticated start ups that never hired the right people for regulatory affairs. Big pharma companies don’t use these services.

25 mb November 3, 2016 at 6:10 pm

I see you have lots of experience. How many new systems have you brought online in big pharma? probably 100s. and big pharma being big pharma has 100s of regulatory and validation people sitting around for the few times each decade they may need them in that location. yep you got me. you know big pharma, how silly of me to think I could pull one past you.

big pharma has their own validation and regulatory people to handle their on going predictable business – the regulation they deal with are known very well as they deal with them with every production batch. But, like every other business that has to temporarily staff up for a project, they hire consultants.

26 The Free Market Is Not God November 3, 2016 at 12:03 pm

In the free market, government is considered to be unnecessary. So it is not well funded, nor is any attention given to making it more efficient. It is simply defunded or destroyed by Congress whenever possible. Still, it manages to exist, because there are not enough Republicans in Congress to keep government agencies from being totally extinguished– and then, Congress is paid to keep the agencies going, in cases where Big Money donors can skew the policies in their own direction.

This is what a gridlock Congress is all about. The GOP doesn’t quite rule Congress enough to get all government agencies eradicated. But it keeps them from getting funded or made more efficient, as a step along the way to eradicating them. The GOP slogan should be “Government doesn’t work. Elect me and I will prove it.”

27 The Original Other Jim November 3, 2016 at 12:39 pm

>In the free market, government is considered to be unnecessary.

Wrong. Back to third grade with you, Spanky. Let us know when you finish up.

28 Troll me November 3, 2016 at 2:00 pm

38% public sector share of GDP is capitalism , 40?% is communism. Right?

29 rayward November 3, 2016 at 12:08 pm

In my business (law) clients seek my counsel (1) to identify legal issues in connection with a proposed course of action and (2) for advice and guidance to assure legal compliance. I’d prefer if clients would pay me for (1) but they won’t unless I provide (2). Drats!

30 Crofton November 3, 2016 at 12:23 pm

“… the agency is struggling to hire and retain staff because pharmaceutical companies lure them away.”

What (??) — that sacred government regulatory agency draws its noble staff from the very same personnel pool as the despicable drug companies ? An outrage.

…but, but government “regulators” are supposed to be so much more expert & ethical than drug company people — that’s the fundamental reason for the very existence of regulators.

…must be some kind of super magic fairy dust sprinkled on civilians when they are hired as government regulators… that transforms them into superior beings.

…and surely the government does NOT want to hire regulatory-personnel who are so strongly motivated by money/salary — they are too easy to bribe/corrupt.

31 Troll me November 3, 2016 at 2:07 pm

“surely the government does NOT want to hire regulatory-personnel who are so strongly motivated by money/salary — they are too easy to bribe/corrupt”

This logic might be relevant, but there’s also the logic that corruption is reduced when you pay them the market rate. So, for example, in countries where corruption is a huge problem, one of the standard suggestions is to increase public sector salaries to the extent that the bribery money is not that appealing in consideration of a potentially stable lifelong job which holds much potential to contribute to broader societal interests.

32 Jay November 3, 2016 at 12:36 pm

Cue communists blaming the private sector for paying employees too much. Institute a maximum wage at the rate the FDA is able to pay. That will put the private sector in its place!

33 Troll me November 3, 2016 at 2:45 pm

Is the US medical profession earning their keep in the sense of producing the same 2-3 times quality/quantity output as their differential wage compared to other countries would imply?

No, they produce worse average results. So let’s stop pretending that econ 101 market logic applies.

34 Alain November 3, 2016 at 9:15 pm

“No, they produce worse average results.”

LOL

35 Troll me November 5, 2016 at 10:15 pm

I don’t think it’s deep enough, but that’s probably a good thing to ensure good flow of air: https://www.amazon.com/KidKraft-00130-Kidkraft-Backyard-Sandbox/dp/B001U4ZEZQ

36 Student November 3, 2016 at 12:50 pm

I only see 41 vacancies open to the public and 93 open for federal employees in all of the FDA as of today… So….

https://www.usajobs.gov/Search/GetAdvancedSearchResults/

37 adam November 3, 2016 at 1:10 pm

So they haven’t even made it through the process to post most of the openings….

38 Student November 3, 2016 at 1:38 pm

How can someone taking another job while waiting for an offer before a position is even posted? If it is true that there is 600 vacancies (which i doubt) and they only have 100 posted, that indicates they dont have the authorization to post the position. That is almost always a budgetary issue. Its difficult to budget when one is continuously operating on a short term continuing resolution.

Either way, i am not sure the patient cares.

39 kevin November 3, 2016 at 2:41 pm

Those vacancies represent a position that is open. There are likely many openings behind each position.

40 Student November 3, 2016 at 8:13 pm

See page 255 of their FY 2017 budget justification.

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM485237.pdf

The center for drug research is seeking to add less than 10 FTEs. They added about 450 between FY 2015 and FY 2016.

They are posting about 100 positions or about 2% of their staff. That seems like replacement.

What am I missing here? Where is there any evidence for this? Sounds like the director feels his staff is overworked and wanted to add staff and got overruled by either HHS admin or OMB or congress.

41 Student November 3, 2016 at 8:14 pm

What am I missing here?

42 Student November 3, 2016 at 8:19 pm

Oops. Looked at the wrong column. The number was about 250 not 450.

43 JFA November 3, 2016 at 1:15 pm

I had an interview with the CDER at the FDA and at another government agency around the same time. The hiring processes were vastly different. At this other agency (within Health and Human Services), from first contact for scheduling the first interview to the final offer, the process took about a week and a half. At the CDER, I had my second interview about 2 weeks after first contact. About a week later, I contacted them to see if they had made a decision, and they said there were some bureaucratic roadblocks and that I should contact them in a week. A few days later I received the job offer from the other agency. After contacting them again, CDER said that the bureaucratic hurdles were holding them up and they hoped to get the issues resolved in the coming *months*.

44 GoneWithTheWind November 3, 2016 at 1:34 pm

Perhaps they should change the system such that unless the FDA actively rejects a drug it can be marketed for the use intended. Throw in a short waiting period of say, six months for the FDA to come up with a reason to not allow the drug to go to market. Obviously some will argue that potentially harmful drugs will be available without adequate testing and people will be harmed or killed by this. The question then becomes isn’t that effectively the same result we now have by delaying effective drugs for years before the FDA gets around to approving them?

45 Troll me November 3, 2016 at 1:54 pm

The public sector must be required to be penny rich dollar poor when it comes to hiring people in markets where the private sector competes heavily for talent. We need middling accountants, middling scientists, and mid-level talent all around.

Otherwise, it would be outrageous to find that the government pays them similar rates for similar talents despite often managing budgets orders of magnitude larger and despite having a diversity of other responsibilities that no private actors are taking on.

(Actually, though, due to a number of distortions, the price signal in US pharma is almost certainly heavily inflated. That won’t help the FDA find people, but it means they’re probably paying more than they would have to in a health services and pharma market where various manipulations did not result in the present level of profit and revenues in that sector of the economy. But that’s the market for you … )

46 prognostication November 3, 2016 at 1:58 pm

The federal hiring system is a disaster. At many agencies, safeguards nominally in place to keep the hiring process “objective” lead to the most qualified people being screened out by OPM before the actual hiring agency even gets a look at them. Meanwhile, the agencies that want to backdoor the process for specific positions still do so by telling preferred candidates exactly how to answer the application questions, even when it requires bending the truth.

47 Troll me November 3, 2016 at 3:10 pm

“the most qualified people being screened out by OPM”

Do you have a disgruntled friend who didn’t get the job they thought they deserve, or is there some basis to this?

48 kevin November 3, 2016 at 3:33 pm

there is some basis to this. Often the people deemed most qualified are simply those most willing to exaggerate/lie on an application. And once they’ve been “selected” its very difficult do unselect and look at other candidates, even after an interviewer determines immediately that a resume isn’t legit.

49 prognostication November 3, 2016 at 3:58 pm

In fact, exactly the opposite — I had a friend who was told by a hiring manager at an agency who wanted to interview her that she had to give exactly a set of answers the manager specified to the KSAs portion of the application or it wouldn’t get through OPM. Also, I myself have been told by a recruiter for another agency that if you can’t nail every single one of the KSAs in an ad, OPM will never forward you to the hiring agency.

50 David Ptr November 4, 2016 at 10:20 am

There is some basis to this. Veterans’ hiring preference can be very powerful, and any minimally qualified candidate with veterans’ preference will be selected over any other candidate without. Veterans make up almost half of all federal hires, and this isn’t coincidental. To a great extent, federal civil service functions as a job program for military retirees.

51 Bill November 3, 2016 at 2:39 pm
52 mulp November 3, 2016 at 3:11 pm

No, it has to do with this, from the highly objective Newsmax

Federal government workers earn 78 percent more than their counter parts in the private sector, a new study conducted by the Cato Institute reveals.

Private employees earned an average of $56,350 in 2014, while federal workers earned an average of $84,153 that year.

Based off of figures from the U.S. Bureau of Economic Analysis (BEA), the Cato Institute notes that when adding in benefits pay for federal workers, the difference in pay becomes even more dramatic. As federal employees made $119,934 in total compensation last year, private sector workers only earned $67,246, a difference of over $52,000, or 78 percent.

“Since the 1990s, federal workers have enjoyed faster compensation growth than private-sector workers,” according to Chris Edwards, the director of tax policy studies at the Cato Institute. “In 2014 federal workers earned 78 percent more, on average, than private-sector workers. Federal workers earned 43 percent more, on average, than state and local government workers.”

http://www.newsmax.com/t/newsmax/article/695508?section=US&keywords=government-jobs-cato-institute-government-pay-income&year=2015&month=10&date=09&id=695508&aliaspath=%2FManage%2FArticles%2FTemplate-Main&oref=www.google.com

53 Troll me November 3, 2016 at 3:16 pm

In other news, people responsible for multi-million dollar budgets tend to get paid more than the person who takes out the trash.

54 JFA November 3, 2016 at 4:02 pm

From the Cato report summarizing studies from the CBO, Heritage Foundation, and AEI: These studies “found large differences based on education levels. Among less-educated workers, the federal government pays better, but among highly educated workers, the private sector pays better.”

55 Student November 3, 2016 at 8:15 pm

Yep.

56 Thomas Sewell November 3, 2016 at 9:21 pm

Hey, at least they’ve figured out a way to limit “inequality” in government jobs… just don’t pay actually higher skilled/educated workers enough to be able to hire them…. and as a bonus, also ensure those you do hire for the post are the least-qualified, i.e. the ones who couldn’t find a better job elsewhere in the meantime.

57 Student November 3, 2016 at 9:40 pm

Dar gar rar. Dumb.

58 Troll me November 5, 2016 at 10:21 pm

It would be theoretically plausible to get the observed result by that method.

But I think it’s mostly because it is good to have a body of experience that functions well in positions which require less qualified staff, whereas paying less than private markets for positions which require more qualifications and experience might ensure that you’re not attracting too many money grubbers into the public service.

59 Thanatos Savehn November 3, 2016 at 5:18 pm

Complexity and low risk tolerance explain a good bit of FDA’s drug approval woes. Why does a drug that a few thousand people will take every year cost 10x as much to get approved as a new GA aircraft design that a few thousand people will fly in each year? A difference in risk tolerance. Why has the FDA approved so many products that don’t work as advertised and why has the FAA approved so few? Complexity. The variance in human response to modern drugs designed to tweak e.g. a protein’s shape is often enormous and nobody can say why. Paralysis is the commonest response of the risk averse when faced extreme uncertainty. Maybe the sheeple have gotten exactly what they want from their government.

60 carlolspln November 3, 2016 at 7:09 pm

“High-value, potentially life-saving drugs are being delayed because the FDA is constrained from paying market rates”

How do you know?

Show your work.

61 libert November 3, 2016 at 7:54 pm

Why? This is economic theory. No evidence needed.

62 libert November 3, 2016 at 7:57 pm

Private sector Pays better than government for people with the same skills and experience. News at 11.

63 Alex November 4, 2016 at 12:59 am

Currently, new drugs must prove safety and efficacy to be approved. Only safety should be required, not efficacy. And the standard for safety should be very explicitly defined by Congress, so that the FDA doesn’t block approvals of safe drugs.

64 John November 4, 2016 at 10:36 am

I work for a private firm and I can’t get anyone hired, either. I read recently that the average time to hire people across corporate America has doubled in ten years. The feds may be the leaders in bureaucratic obstacles, but I am afraid that it is a society-wide problem. And Alex, what is it like to hire a new tenure-track professor in your department? Would you say the process is rapid and efficient? If you feel that the glacial pace of the academic hiring process is important for some reason, why should the FDA be any different?

65 Student November 4, 2016 at 12:10 pm

I know. Can you imagine how long it would take a department at GMU to hire even 10 tenure track associate professors. And those candidates don’t have to divest their investment portfolios or go through as rigorous a back ground investigation.

Also, is there any difference in the time it takes to hire faculty between public and private universities?

66 orthodoc November 4, 2016 at 10:01 pm

Speaking as someone in the private sector who (until recently) was on the Center for Devices and Radiological Health panel for devices, I can say that the paperwork required is so onerous as to be disqualifying. The financial disclosure alone is nuts – every stock in every mutual fund I might have.

Forget it.

67 Troll me November 5, 2016 at 10:27 pm

You can assign someone else, for example a financial advisor or financial services company, to manage your investments instead of having to worry about running into conflict of interest.

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